QT105: Complaint Handling & Biovigilance Reporting

1 or 2-day course:

Complaint handling systems have come under intense scrutiny by the FDA in recent years. This course will examine the current industry FDA environment and seek to provide you with knowledge and tools for survival. It will provide a step-by-step guide to the setting-up, managing and auditing a Complaint Handling System for today’s human tissue or medical device industry environment.

  • FDA Requirements for Complaint Handling
  • Understand the present FDA requirements and expectations for complaint handling, via case studies of recent industry-FDA “events”;
  • Write a Complaint Handling &Investigation Procedure, and associated Forms;
  • Documenting complaints;
  • Analyzing and investigating complaints to identify trends;
  • Responding to complaints;
  • Identify probable root causes, and implement corrective action
  • Develop a “Decision Tree” for identifying reporting requirements;
  • HCT/P Reporting and Adverse Reaction Reporting
  • Automated Complaint Handling and Investigation systems